This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy.

The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.

The net change of height velocity between Group 2 and Group 3 and the net change in predicted height between Group 2 and Group 3. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma E2 level to document the dose-response effect of the applied prescription and uterine dimensions to quantitate the estrogenic effect on growth and development of the uterus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3.

60 subjects will be recruited from participating Pediatric Endocrinology Clinics in the United States.

Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of GH therapy prior to the study.

Subjects may not have had any estrogen prior to the study. All subjects must be breast stage 1 and euthyroid prior to the study

Those on thyroid medication will continue the appropriate thyroid replacement therapy during the study.

Exclusion Criteria:

On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00870220